Patent Owner’s Demonstratives
`US Endodontics, LLC, v. Gold Standard Instruments, LLC
`
`Case PGR2015-00019 | Patent 8,876,991 B2
`
`
`US Endodontics, LLC, v. Gold Standard Instruments, LLC
`
`Case PGR2015-00019 | Patent 8,876,991 B2
`
`
`
`Burden of Proof
`
`cmmcmne.mm
`
`2
`
`
`
`
`Burden of Proof
`
`● Petitioner must prove unpatentability
`by a preponderance of the evidence
`– 35 U.S.C. § 326(e)
`● Petitioner argues—incorrectly—that Patent
`Owner has the burden to demonstrate
`patentability
`– Petitioner’s Reply at 1
`● Petitioner has not carried its burden
`
`3
`
`
`
`Background
`
`Background
`
`4
`
`
`
`Background – State of the Art in 2005 –
`Superelasticity was viewed as a Benefit
`
`Patent Owner’s Response at 2, 9, 13; Ex. 2030 at 9:33–55
`
`5
`
`
`
`Background – State of the Art in 2005 –
`Superelasticity was viewed as a Benefit
`
`Patent Owner’s Response at 2, 3 n.2, 9, 13; Ex. 2031 at ¶17
`
`6
`
`
`
`Background – State of the Art in 2005 –
`Superelasticity was viewed as a Benefit
`
`Patent Owner’s Response at 10; Ex. 2037 at 297
`
`7
`
`
`
`Problems with Superelastic NiTi Files
`
`Patent Owner’s Response at 8
`
`8
`
`
`
`Dr. Luebke Recognized Problems with Superelastic Files
`
`File Size 25 with 04 taper
`with pressure applied
`
`File Size 25 with 04 taper
`with pressure released,
`file returns to natural
`straight orientation
`
`(Petitioner’s) Ex. 1008 at 108–16 (prosecution history of related U.S. Patent No. 8,727,773)
`
`9
`
`
`
`Dr. Luebke’s process results in deformable files
`that can maintain deformed shape
`
`File Size 25 with 04 taper
`natural straight shape before
`pressure is applied
`
`File Size 25 with 04 taper
`curved state after bending
`pressure applied and after
`pressure released. It does not
`return to original state
`
`(Petitioner’s) Ex. 1008 at 108–16 (prosecution history of related U.S. Patent No. 8,727,773)
`
`10
`
`
`
`Background - The ’991 Patent – Figure 6
`
`’991 patent (Ex. 1001) at Fig. 6
`
`11
`
`
`
`Aspects of Dr. Luebke’s Invention
`
`’991 patent (Ex. 1001) at 2:60–3:5
`
`12
`
`
`
`Challenged Claims of the ‘991 Patent
`
`Claims 12-16 are at issue
`
`’991 patent (Ex. 1001)
`
`13
`
`
`
`Claim Construction
`
`Claim Construction
`
`14
`
`
`
`Claim Construction in Institution Decision
`
`The Board properly construed the “wherein” clause
`in its Institution Decision
`
`Institution Decision at 23
`
`15
`
`
`
`Claim Construction in Institution Decision
`
`Institution Decision at 23, 24
`
`16
`
`
`
`Claim Construction in Institution Decision
`
`The Board was correct in rejecting
`US Endo’s proposed constructions:
`
`Institution Decision at 24
`
`17
`
`
`
`Claim Construction – Dr. Goldberg’s Testimony
`
`Dr. Goldberg’s testimony regarding
`the use of Af to predict crystal structure:
`
`Q. Okay. So it’s fair to
`say you can’t use the A
`sub F itself to determine
`what the crystal
`structure is of an alloy?
`
`A. You would need to
`know what temperature
`you’re at and what the
`processing had been,
`what’s currently going
`on. This—yes. That’s it.
`
`Q. Okay. So you would
`agree that if there’s a
`hysteresis between the
`austenite transition
`temperature and the
`martensite transition
`temperature, if you’re
`between those two
`temperatures, the crystal
`structure can depend on
`whether you’re coming
`from the cooling side or
`from the heating side. Is
`that fair?
`
`A.
`I think that’s fair.
`Observations ¶2; Ex. 2047 at 49:18–25; 51:18–52:2; and 53:8–18
`
`18
`
`
`
`Claim Construction – Dr. Goldberg’s Testimony
`
`Dr. Goldberg’s testimony regarding the use of crystal
`structure to predict bending behavior:
`
`Q. When we were talking earlier about permanent deformation, if a nickel
`titanium alloy is superelastic nickel titanium alloy, will it permanently
`deform when it is in the austenitic phase?
`
`It is somewhat of a compound question because, as I said earlier,
`A.
`I don’t think you can look at the crystal structure alone, such as the
`austenitic phase and infer what the mechanical properties are.
`So you are asking it – the main question is, is it permanently
`deformable or not, and for that I would just have to see the mechanical
`property data. So I’m not trying to avoid your question, but I have
`explained that I don’t think you can infer the mechanical properties
`from the phase alone. You would have to see the mechanical. You
`would actually have to see the mechanical properties.
`
`Patent Owner’s Response at 29–30; Ex. 2014 at 112:20–113:19
`
`19
`
`
`
`Claim Construction in Institution Decision
`
`The Board was correct in rejecting
`US Endo’s proposed constructions:
`
`Institution Decision at 23–24
`
`20
`
`
`
`Claim Construction
`
`Petitioner did not challenge
`the Board’s claim construction
`
`Petitioner’s Reply
`
`21
`
`
`
`Claim Construction – Dr. Goldberg’s Testimony
`
`Patent Owner’s Response at 19; Ex. 1002 (Goldberg) at ¶133
`
`22
`
`
`
`Claim Construction
`
`Petitioner did not argue
`that Goldberg ¶133 is incorrect
`
`Petitioner’s Reply
`
`23
`
`
`
`Claim Construction
`
`Patent Owner’s Response at 17
`
`24
`
`
`
`Enablement
`
`Elablement
`
`25
`
`
`
`The Challenged Claims of the ’991 Patent
`are Enabled
`
`“Without undue experimentation or effort or expense
`the combinations which do not work will readily be
`discovered and, of course, nobody will use them and
`the claims do not cover them.”
`“We hold that the evidence as a whole, including the
`inoperative as well as the operative examples,
`negates the PTO position that persons of ordinary skill
`in this art, given its unpredictability, must engage in
`undue experimentation to determine which complexes
`work. The key word is ‘undue,’ not ‘experimentation.’”
`In re Angstadt, 537 F.2d 498, 503–04 (CCPA 1976)
`
`26
`
`
`
`The Challenged Claims of the ’991 Patent
`are Enabled
`
`Patent Owner’s Response at 18
`
`27
`
`
`
`The Challenged Claims of the ’991 Patent
`are Enabled
`
`Institution Decision at 17
`
`28
`
`
`
`The Challenged Claims of the ’991 Patent
`are Enabled
`
`“Enablement is not precluded by the necessity for
`some experimentation such as routine screening. . . .
`‘The key word is ‘undue,’ not ‘experimentation.’”
`“The test is not merely quantitative, since a
`considerable amount of experimentation is
`permissible, if it is merely routine . . .”
`In re Wands, 858 F.2d 731, 736–37 (Fed. Cir.
`1988) (quoting In re Jackson, 217 USPQ at 807)
`
`29
`
`
`
`The Challenged Claims of the ’991 Patent
`are Enabled
`
`Dr. Goldberg’s testimony regarding
`his understanding of “undue” experimentation:
`
`Q.
`
`So it's fair to say that your opinion
`regarding undue experimentation is based on
`the volume of testing that would be required
`to practice the claims of the ’991 patent?
`Mr. Ginsberg: Objection to form.
`
`A.
`
`Yes. I believe so.
`
`Observations at ¶1; Ex. 2047 at 23:24–24:19
`
`30
`
`
`
`The Challenged Claims of the ’991 Patent
`are Enabled
`
`Dr. Goldberg’s testimony regarding the bend testing
`in ISO 3630-1:
`
`Q.
`
`So would you consider the stiffness testing in
`Section 7.5 of the ISO to be routine testing?
`Mr. Ginsberg: Objection to the form of the question.
`
`A. Well, it’s routine to the extent that that’s the
`specification, and some people use that
`specification test. But there’s other methods
`also.
`
`Observations at ¶12; Ex. 2047 at 14:6–14
`
`31
`
`
`
`The Challenged Claims of the ’991 Patent
`are Enabled
`
`Mr. Kozak’s testimony regarding the bend testing
`in ISO 3630-1:
`
`Q.
`
`Okay. You would agree that the ISO 3630
`stiffness testing was normal testing in terms of
`the effort it took and the instrumentation
`required?
`Mr. Ginsberg: Objection to form.
`
`A.
`
`Yes.
`
`Patent Owner’s Response at 28; Ex. 2041 at 55:8–13
`
`32
`
`
`
`The Challenged Claims of the ’991 Patent
`are Enabled
`
`Mr. Kozak’s testimony regarding the bend testing
`in ISO 3630-1:
`
`Q.
`
`A.
`Q.
`
`A.
`
`So you had not performed the stiffness testing in
`other endodontic files prior to this work; is that
`correct?
`That is correct.
`Was this testing very difficult for you?
`Mr. Ginsberg: Objection to form.
`I would not describe it as difficult.
`
`Patent Owner’s Response at 28; Ex. 2041 at 52:24–53:8
`
`33
`
`
`
`The Challenged Claims of the ’991 Patent
`are Enabled
`
`Dr. Goldberg’s testimony regarding the selection of heat
`treatment times:
`
`“In my opinion, it would have been obvious to one of
`ordinary skill in the art to accept Khier’s recommendation
`and use a vacuum or inert atmosphere when implementing
`the heat treatments described by Kuhn and Pelton. Some
`adjustment to Kuhn’s treatment times might be required
`since Kuhn’s salt bath might heat the files more quickly than
`a gaseous atmosphere; however, in my opinion, this
`adjustment would have been a matter of routine
`experimentation.”
`
`Patent Owner’s Response at 28; Ex. 2010 at ¶169
`
`34
`
`
`
`The Challenged Claims of the ’991 Patent
`are Enabled
`
`Dr. Goldberg’s testimony regarding the disclosure of
`McSpadden (Ex. 1031) and the knowledge of one of skill in
`the art:
`Q. And so we were talking about McSpadden as well, which is Exhibit
`1031. And I think you had testified that it likewise did not disclose
`temperatures or durations for the heat treatment process; correct?
`
`A. Correct.
`
`Q.
`
`Is it your opinion that, based on the disclosure of McSpadden—
`again, referring to the specification and the information he provides
`about heat treatments—that that would be sufficient to allow one
`skilled in the art to make a file that was capable of being precurved?
`
`Mr. Ginsberg: Objection to form of the question.
`
`A. Yes. To the extent that he’s trying to achieve that outcome, yes.
`
`Observations at ¶3; Ex. 2047 at 153:16–155:6
`
`35
`
`
`
`The Challenged Claims of the ’991 Patent
`are Enabled
`
`Dr. Goldberg’s testimony regarding the disclosure of
`Matsutani (Ex. 2044):
`
`Q.
`
`A.
`Q.
`
`A.
`
`And I believe we previously discussed that the Matsutani 815
`patent does not disclose specific times or temperatures for
`the heat treatments to remove the superelasticity from a
`portion of the shank; is that correct?
`That was correct.
`And so you agree that aside from the reference to superelastic
`nickel titanium, Matsutani does not disclose any other
`composition ranges for the nickel titanium alloys in the
`endodontic files.
`Mr. Ginsberg: Objection to form of the question.
`Right. He's not specifying any compositional ranges. He just
`says nickel titanium alloy.
`
`Observations at ¶4; Ex. 2047 at 127:20–129:20
`
`36
`
`
`
`The Challenged Claims of the ’991 Patent
`are Enabled
`
`Dr. Goldberg’s testimony regarding the knowledge of one of
`skill in the art:
`
`Q.
`
`I'm just asking you whether, as a person skilled
`in the art, Matsutani by itself provides adequate
`disclosure to instruct a person skilled in the art how
`to achieve the expressed goal of removing
`superelasticity from a portion of the shank.
`
`Mr. Ginsberg: Objection to form of the question.
`
`A.
`
`I guess one skilled in the art would know that
`there are temperatures you could heat these to
`eliminate superelasticity.
`
`Observations at ¶5; Ex. 2047 at 144:2–20
`
`37
`
`
`
`The Challenged Claims of the ’991 Patent
`are Enabled
`
`Dr. Goldberg’s testimony regarding the disclosure
`of the ’991 patent:
`
`A.
`
`Q. So the Luebke ’991 patent provides more information about heat treatment
`temperatures than the Matsutani ’815 patent; correct?
`Mr. Ginsberg: Objection to form.
`It provides a specific temperature to achieve the result, and I don't see a specific—
`any temperatures in the Matsutani.
`Q. Okay. And likewise, the Luebke ’991 patent provides more information about the
`heat treatment duration than the Matsutani ’815 patent; correct?
`Mr. Ginsberg: Objection to form.
`A. Again, in that one example, he gives 75 minutes, and I didn't see a specific times in
`Matsutani.
`Q. And the Luebke ’991 patent discloses more information about the range of nickel
`titanium alloy compositions than the Matsutani patent; correct?
`Mr. Ginsberg: Objection to form.
`A. Correct. It gives a range of compositions that can be used. The Matsutani looks like
`it either describes just nickel titanium or nickel -- it does also use the phrase "nickel
`titanium alloy," so maybe that would suggest a possible range.
`
`Observations at ¶4; Ex. 2047 at 138:4–139:11
`
`38
`
`
`
`The Challenged Claims of the ’991 Patent
`are Enabled
`
`The claims require a “superelastic” nickel titanium alloy
`
`Dr. Goldberg’s testimony regarding the scope of the
`term “superelastic”:
`Q.
`Now, Dr. Goldberg, only a narrow
`composition range of nickel titanium alloys
`exhibit superelastic behavior; is that fair?
`Mr. Ginsberg: Objection to form.
`I think that’s fair.
`
`A.
`
`Observations at ¶7; Ex. 2047 at 78:2–20
`
`39
`
`
`
`The Challenged Claims of the ’991 Patent
`are Enabled
`
`Patent Owner’s Reponse at 20
`
`40
`
`
`
`The Challenged Claims of the ’991 Patent
`are Enabled
`
`Dr. Goldberg’s testimony regarding Petitioner’s 1st testing:
`
`Dr. Goldberg—
`Q.
`Yes.
`A.
`Q. —who picked the temperatures at which the
`testing was going to be done?
`. . .
`I’m not sure who picked the temperatures. The
`reports that I was given reported that those were
`the temperatures that were used.
`
`A.
`
`Patent Owner’s Reponse at 20; Ex. 2039 at 98:3–99:21
`
`41
`
`
`
`The Challenged Claims of the ’991 Patent
`are Enabled
`
`Dr. Goldberg’s testimony regarding Petitioner’s 2nd testing:
`
`Q.
`
`A.
`
`Did you choose the times and temperatures that
`ITS used?
`No.
`
`Observations at ¶4; Ex. 2047 at 20:13–22
`
`42
`
`
`
`The Challenged Claims of the ’991 Patent
`are Enabled
`
`Dr. Goldberg’s testimony regarding
`the scope of Petitioner’s testing:
`
`Q.
`
`A.
`Q.
`
`A.
`Q.
`
`A.
`Q.
`A.
`Q.
`A.
`
`Are you aware of any heat treatments that were done by Petitioner at
`400 degrees Celsius?
`No.
`Are you aware of any heat treatments that were done by Petitioner in
`connection with this PGR at 500 degrees Celsius?
`No.
`Are you aware of any heat treatments that were done by Petitioner in
`connection with this PGR at 600 degrees Celsius?
`No.
`What about 700 degrees Celsius?
`No.
`What about 800 degrees Celsius?
`No.
`
`Observations at ¶9; Ex. 2047 at 68:22–69:23
`
`43
`
`
`
`The Challenged Claims of the ’991 Patent
`are Enabled
`Testing submitted by Patent Owner demonstrates heating at
`300ºC results in file with claimed deformation properties
`
`Patent Owner’s Response at 4, 23; Ex. 2034 at 381–393, 390
`
`44
`
`
`
`The Challenged Claims of the ’991 Patent
`are Enabled
`
`Ex. 2034 at 381–393 provides a post-bend testing photo of
`files heat-treated at 300°C:
`
`Patent Owner’s Response at 4, 23; Ex. 2034 at 381–393, 392
`
`45
`
`
`
`Written Description
`
`Writte 11 De sc Iip tion
`
`46
`
`
`
`Claims 12–16 of the ’991 Patent have
`Adequate Written Description Support
`
`’991 patent (Ex. 1001) at 2:60–3:5
`
`47
`
`
`
`Claims 12–16 of the ’991 Patent have
`Adequate Written Description Support
`
`Patent Owner’s Response at 21; ’991 patent (Ex. 1001) at 4:16–29
`
`48
`
`
`
`Claims 12–16 of the ’991 Patent have
`Adequate Written Description Support
`
`’991 patent (Ex. 1001) at 3:53–60
`
`49
`
`
`
`Claims 12–16 of the ’991 Patent have
`Adequate Written Description Support
`
`Patent Owner’s Response at 12, 30; ’991 patent (Ex. 1001) at 8:37–62
`
`50
`
`
`
`Claims 12–16 of the ’991 Patent have
`Adequate Written Description Support
`
`Patent Owner’s Response at 12; ’991 patent (Ex. 1001) at Fig. 6
`
`51
`
`
`
`Claims 12–16 of the ’991 Patent have
`Adequate Written Description Support
`
`“It is not necessary that the application describe the claim
`limitations exactly, but only so clearly that persons of ordinary skill
`in the art will recognize from the disclosure that appellants
`invented processes including those limitations.”
`“The primary consideration is factual and depends on the nature
`of the invention and the amount of knowledge imparted to
`those skilled in the art by the disclosure.”
`“Mere comparison of ranges is not enough . . . We must decide
`whether the invention appellants seek to protect by their claims is
`part of the invention that appellants have described as theirs in
`the specification.”
`In re Wertheim, 541 F.2d 257, 262–63 (CCPA 1976) (internal
`citations omitted)
`
`52
`
`
`
`Claims 12–16 of the ’991 Patent have
`Adequate Written Description Support
`
`“If lack of literal support alone were enough to
`support a rejection under §112, then the
`statement of In re Lukach . . . , that ‘the
`invention claimed does not have to be
`described in ipsis verbis in order to satisfy the
`description requirement of §112,’ is empty
`verbiage.”
`In re Wertheim, 541 F.2d 257, 265 (CCPA
`1976) (internal citations omitted)
`
`53
`
`
`
`Claims 12–16 of the ’991 Patent have
`Adequate Written Description Support
`
`“We have made clear that the written description
`requirement does not demand either examples or
`an actual reduction to practice.”
`Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336,
`1352 (Fed. Cir. 2010)
`
`54
`
`
`
`Claims 12–16 of the ’991 Patent have
`Adequate Written Description Support
`
`“[T]hat a claim may be broader than the
`specific embodiment disclosed in the
`specification is in itself of no moment.”
`In re Rasmussen, 650 F.2d 1212, 1215
`(CCPA 1981)
`
`55
`
`
`
`Claim 14 of the ’991 Patent has Adequate
`Written Description Support
`
`● ‘991 patent provides adequate disclosure for
`heating from 300ºC up to but not equal to the
`melting point of the superelastic nickel
`titanium alloy recited in claim 14
`
`● In re Wertheim, 541 F.2d 257 (C.C.P.A. 1976)
`controls
`
`● The temperature range in claim 14 does not
`go beyond those described in the
`specification
`
`Patent Owner’s Response at 33–39
`
`56
`
`
`
`If the Board concludes the claims are
`enabled and adequately supported, there
`is no basis to reach Grounds 3, 4, 6 or 7
`
`57
`
`
`
`Grounds 6 & 7 based on Kuhn
`
`Grounds 6 & 7 based on Kuhn
`
`58
`
`
`
`Kuhn Does Not Anticipate or Render Obvious
`the Challenged Claims of the ’991 Patent
`
`● Kuhn does not teach or suggest making
`a permanently deformable file
`
`● Kuhn does not heat treat the entire shank
`
`● Kuhn teaches away
`
`59
`
`
`
`Kuhn Does Not Teach or Suggest
`Making a Permanently Deformable File
`
`● Kuhn investigated fatigue properties of files (Ex. 1030 at 716)
`
`● Kuhn annealed files at various temperatures for only
`10-15 minutes (Ex. 1030 at 717)
`
`● Petitioner concedes that file heated at 510°C does not
`show permanent deformation (IPR2015-00632 Paper 2 at 32)
`
`● Petitioner relies solely on file heated at 400°C (10 min)
`(Paper 2, 61–62)
`
`Patent Owner’s Response at 41–42, 48–49; Ex. 1030 at 716, 717
`
`60
`
`
`
`The Kuhn 2002 Article Itself Confirms That
`the Tested Files Recover Their Original State
`
`Kuhn (2002)
`
`Patent Owner’s Response at 42; Ex. 1030 at 716
`
`61
`
`
`
`The Kuhn 2002 Article Itself Confirms That
`the Tested Files Recover Their Original State
`
`“[T]he reference at the end of the sentence to the transformation temperatures being
`‘close to room temperature’ supports Petitioner’s arguments that this disclosure refers
`to non-heat-treated files, because Kuhn reports that files had a transformation
`temperature of 40ºC after treatment at 400ºC. Id. at 719” Institution Decision at 35.
`
`Patent Owner’s Response at 42, 44–45, 48; Ex. 1030 at 719–720
`
`62
`
`
`
`Kuhn’s Files Remained Superelastic
`
`Patent Owner’s Response at 5–6, 42–43; Ex. 2035
`
`63
`
`
`
`Files Heated at 400ºC Pursuant to Kuhn
`Are Superelastic
`
`Patent Owner’s Response at 5–6, 42–43; Ex. 2036 at 7
`
`64
`
`
`
`Kuhn’s Files Remained Superelastic (returned
`to original orientation, or close thereto)
`
`Patent Owner’s Response at 5–6, 42–43; Ex. 2036 at 7–11
`
`65
`
`
`
`Kuhn Teaches That Stiffness Is Important and Suggests
`at Most Pre-Machining Recovery Heating
`
`Patent Owner’s Response at 48–49; Ex. 1030 at 720
`
`66
`
`
`
`Kuhn Teaches That Stiffness Is Important and Suggests
`at Most Pre-Machining Recovery Heating
`
`Kuhn suggests “recovery” heat treatments
`prior to file machining
`
`Patent Owner’s Response at 48–49; Ex. 1030 at 720
`
`67
`
`
`
`The Kuhn 2002 Article is a Continuation
`of the Kuhn 2001 Article
`
`Kuhn (2001)
`
`Patent Owner’s Response at 50–51; Ex. 1030 at 716, 720
`
`68
`
`
`
`Kuhn 2001 (Ex. 2017) Corroborates the Superelastic
`Nature of the Heat Treated Files in Kuhn 2002 (Ex. 1030)
`
`Kuhn (2001)
`
`* * *
`
`* * *
`
`Patent Owner’s Response at 50–51; Ex. 2017 at 517
`
`69
`
`
`
`The Superelastic Files in Kuhn 2001 (Ex. 2017)
`Had to Be Clamped Down for SEM Testing
`
`Kuhn (2001)
`
`Patent Owner’s Response at 50–51; Ex. 2017 at 518
`
`70
`
`
`
`Kuhn Teaches Away From the Claimed Invention
`
`Kuhn concludes that
`stiffness is very
`important and heat
`treatments are not
`required
`
`Kuhn suggests
`“recovery” heat
`treatments prior to file
`machining
`
`Patent Owner’s Response at 48–49; Ex. 1030 at 720
`
`71
`
`
`
`Kuhn Does Not Heat Treat the Entire Shank
`
`Kuhn states that
`the files are cut
`with a diamond
`saw
`
`Table 1 states that
`the heat treatment
`was on the “active
`part” of file
`
`Patent Owner’s Preliminary Response at 36–38; Patent Owner’s Response at 57; Ex. 1030 at 717
`
`72
`
`
`
`Kuhn Does Not Heat Treat the Entire Shank
`
`IPR2015-00632 Final Written Decision at 11; Petitioner’s Reply at 24–25
`
`73
`
`
`
`Kuhn Does Not Heat Treat the Entire Shank
`
`IPR2015-00632 Final Written Decision at 11–12; Petitioner’s Reply at 24–25
`
`74
`
`
`
`Kuhn, Heath and 1992 ISO
`Do Not Render Challenged Claims Obvious
`
`● 2008 ISO 3630-1 (Ex. 1014) is not prior art
`
`● 1992 ISO 3630-1 (Ex. 2026) requires the working part of an
`endodontic file to be a stainless or carbon steel alloy (p. 8, §4.1.1)
`— It does not relate to nickel-titanium endodontic files
`
`● Neither Heath nor 1992 ISO fills in the gaps in Petitioner’s
`proof:
`— The claims are directed to a process, not files
`— Neither Heath nor 1992 ISO mentions heating entire shank
`— Neither Heath nor 1992 ISO suggests permanent
`deformation
`
`● Petitioner does not assert they cure these deficiencies in Kuhn
`
`Patent Owner’s Response at 57–58
`
`75
`
`
`
`End
`
`
`
`76
`
`
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